Roche rolls out new anthrax test
The Swiss healthcare giant Roche says tests to rapidly identify anthrax, should be available to some medical centres in the United States before the end of the week.
The move follows an announcement on Monday by the Minnesota-based Mayo Clinic that it had developed a test for anthrax, which works in one hour and can be used both on people and in the environment. Current tests can take days.
The Mayo test uses technology developed by Roche to look specifically for DNA that is unique to the anthrax bacteria.
Scientists have said a quick test for anthrax — in people or the environment — is the key to saving lives, because antibiotics only work if administered soon after a victim is exposed, and because widespread vaccinations are impractical.
“The first thing people want to know in a case of suspected exposure is whether the agent was in fact anthrax,” said Franklin Cockerill, the Mayo Clinic microbiologist who led the development team.
“Until now, local labs have been able to quickly determine the presence of a bacterium but they can’t tell whether it is anthrax or not. The current process to identify the presence of anthrax may take several days.”
Urgent response needed
Roche is seeking expedited regulatory approval for the anthrax test from the US Food and Drug Administration. The company said tests would initially be offered to laboratories at no charge.
Cockerill said the events of the last few weeks required an extremely rapid response. “This rapid identification will enable doctors to begin more timely treatment of patients who have been exposed to anthrax, and it will more quickly alleviate undue anxiety for people who haven’t been exposed,”
Four people in the United States have died of inhaled anthrax infections in the past month, with another 13 diagnosed cases of either skin or inhalation infections.
“The test genetically analyses DNA from human blood or cell culture or environmental samples to determine the presence of anthrax,” Roche spokeswoman, Jacqueline Wallach told swissinfo.
LightCycler “reads” DNA
The test takes a bit of DNA from the sample and uses a common laboratory method known as polymerase chain reaction (PCR) to make many copies, which can then be more easily examined. Roche’s LightCycler instrument replaces older culture tests for “reading” the DNA.
Roche instruments for performing the tests are already installed in more than 400 US laboratories and in some 1,500 worldwide. Roche has greatly accelerated production to make the ingredients for the tests available as soon as possible.
Some two dozen laboratories will be able to start doing the tests within the next week, the company said. Implementation across the country should follow in the next two months.
Roche and the Mayo Clinic are developing a range of tests to rapidly detect bioterrorism agents in humans and the environment.
Among the tests under development is one to detect smallpox.
by Vincent Landon with agencies
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